Novartis Consumer Health recalls Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-68

Recalled June 12, 2013 · FDA recall D-577-2013 · Novartis Consumer Health

Hazard

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. · FDA Class III

Units

a) 1,043,926 (20-gm) tubes and b) 3,385,481 (100-gm) tubes

Sold at

Nationwide and Puerto Rico, and Panama. Military distribution made.

Description

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.

Product

Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405), Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ.

Manufacturer(s)

Novartis Consumer Health

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →